Ulcerative colitis (UC) is an inflammatory bowel disease characterized by recurrent bouts of rectal bleeding and bloody diarrhea. The initial inflammatory reaction begins in the rectal mucosa in over 95% of cases and may extend in a contiguous fashion to involve the whole colon. Treatment often involves administration of enemas containing corticosteroids, mesalamine and other ingredients which are useful in the largely palliative care and management of the disease. See, for example, Pravda's U.S. Pat. No. 7,312,243 and US Patent Application Publication No. 2010/0184728, the contents of each of which are incorporated herein by reference.
Multi-component enema products must often be compounded by a pharmacist upon need. Budesonide in a multi-component enema product is prone to oxidation and is, therefore, not suitable for long-term storage in a multi-component enema product. While multi-component enema products have shown promise in advancing therapies for patients with UC, there is an on-going need to provide the therapies in a form which would not only have improved shelf life but also in a format which would enhance patient compliance. The present invention addresses this need.